To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.
The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring. The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Tongue Advancement Retainer Device
Senta Clinic
San Diego, California, United States
Visalia Medical Clinic
Visalia, California, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
Safety endpoint will be measured throughout the duration of the study.
Time frame: Approximately 6 weeks
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
Efficacy Endpoint will be measured at baseline and at end of treatment.
Time frame: Approximately 6 weeks
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